Post-hoc analyse On-TIME 2 : Het effect van vroege toediening van hoge dosering Tirofiban bij patiënten met een ST-elevatie myocard infarct: lange termijn follow-up en herdefiniëring

Background: The On-TIME 2 (Ongoing Tirofiban In Myocardial Infarction Evaluation 2) trial showed that early administration of Tirofiban in the ambulance improves ST-segment resolution en reduces early stent thrombosis in patients with STEMI undergoing PCI. Tirofiban improved clinical outcome for the composite of death, recurrent MI and urgent target vessel revascularisation and showed a strong trend towards a lower mortality rate at the 1-year follow-up. The effect of Tirofiban on a longer term is unknown. The results in terms of clinical outcome have not yet been analysed in view of the newest expert consensus definitions. Methods: This post-hoc analysis consists of a long term follow-up of total mortality and a redefinition of ischemic and bleeding events within 30 days. This redefinition will be based on the most recent expert consensus definitions, using the data acquired according to the original On-TIME 2 protocol. All analysis will be by intention-to-treat. Results: 1184 of the 1398 On-TIME 2 patiënts were included in the long-term follow-up. With a mean follow-up of 5.41 years, Tirofiban showed no lower mortality rate (log-rank p = 0.67). 731 of the 1398 patients were included in the redefinition. Although 14 new myocardial infarctions were detected, there was no significant difference between Tirofiban and placebo in the incidence of myocardial infarction (p = 0.46). Patients pre-treated with Tirofiban showed more bleeding events (42 vs 22, p = 0.01) compared to placebo. Conclusions: For a subpopulation of the On-TIME 2, long term-follow with a mean of 5,41 years showed no mortality benefit for Tirofiban. The redefinition of bleeding events for another subpopulation showed a higher incidence of bleeding events for patients pre-treated with Tirofiban.

European Association of Urology Biochemical Recurrence Risk Classification as a Decision Tool for Salvage Radiotherapy-A Multicenter Study

Background: The European Association of Urology (EAU) has proposed a risk stratification for patients harboring biochemical recurrence (BCR) after radical prostatectomy (RP). Objective: To assess whether this risk stratification helps in choosing patients for salvage radiotherapy (SRT). Design, setting, and participants: Analyses of 2379 patients who developed BCR after RP (1989–2020), within ten European high-volume centers, were conducted. Early and late SRT were defined as SRT delivered at prostate-specific antigen values &lt;0.5 and ≥0.5 ng/ml, respectively. Outcome measurements and statistical analysis: Multivariable Cox models tested the effect of SRT versus no SRT on death and cancer-specific death. The Simon-Makuch method tested for survival differences within each risk group. Results and limitations: Overall, 805 and 1574 patients were classified as having EAU low- and high-risk BCR. The median follow-up was 54 mo after BCR for survivors. For low-risk BCR, 12-yr overall survival was 87% versus 78% (p = 0.2) and cancer-specific survival was 100% versus 96% (p = 0.2) for early versus no SRT. For high-risk BCR, 12-yr overall survival was 81% versus 66% (p &lt; 0.001) and cancer-specific survival was 98% versus 82% (p &lt; 0.001) for early versus no SRT. In multivariable analyses, early SRT decreased the risk for death (hazard ratio [HR]: 0.55, p &lt; 0.01) and cancer-specific death (HR: 0.08, p &lt; 0.001). Late SRT was a predictor of cancer-specific death (HR: 0.17, p &lt; 0.01) but not death (p = 0.1).Conclusions: Improved survival was recorded within the high-risk BCR group for patients treated with early SRT compared with those under observation. Our results suggest recommending early SRT for high-risk BCR men. Conversely, surveillance might be suitable for low-risk BCR, since only nine patients with low-risk BCR died from prostate cancer during follow-up. Patient summary: The impact of salvage radiotherapy (SRT) on cancer-specific outcomes stratified according to the European Association of Urology biochemical recurrence (BCR) risk classification was assessed. While men with high-risk BCR should be offered SRT, surveillance might be a suitable option for those with low-risk BCR.</p

European Association of Urology Biochemical Recurrence Risk Classification as a Decision Tool for Salvage Radiotherapy-A Multicenter Study

Background: The European Association of Urology (EAU) has proposed a risk stratification for patients harboring biochemical recurrence (BCR) after radical prostatectomy (RP). Objective: To assess whether this risk stratification helps in choosing patients for salvage radiotherapy (SRT). Design, setting, and participants: Analyses of 2379 patients who developed BCR after RP (1989–2020), within ten European high-volume centers, were conducted. Early and late SRT were defined as SRT delivered at prostate-specific antigen values &lt;0.5 and ≥0.5 ng/ml, respectively. Outcome measurements and statistical analysis: Multivariable Cox models tested the effect of SRT versus no SRT on death and cancer-specific death. The Simon-Makuch method tested for survival differences within each risk group. Results and limitations: Overall, 805 and 1574 patients were classified as having EAU low- and high-risk BCR. The median follow-up was 54 mo after BCR for survivors. For low-risk BCR, 12-yr overall survival was 87% versus 78% (p = 0.2) and cancer-specific survival was 100% versus 96% (p = 0.2) for early versus no SRT. For high-risk BCR, 12-yr overall survival was 81% versus 66% (p &lt; 0.001) and cancer-specific survival was 98% versus 82% (p &lt; 0.001) for early versus no SRT. In multivariable analyses, early SRT decreased the risk for death (hazard ratio [HR]: 0.55, p &lt; 0.01) and cancer-specific death (HR: 0.08, p &lt; 0.001). Late SRT was a predictor of cancer-specific death (HR: 0.17, p &lt; 0.01) but not death (p = 0.1).Conclusions: Improved survival was recorded within the high-risk BCR group for patients treated with early SRT compared with those under observation. Our results suggest recommending early SRT for high-risk BCR men. Conversely, surveillance might be suitable for low-risk BCR, since only nine patients with low-risk BCR died from prostate cancer during follow-up. Patient summary: The impact of salvage radiotherapy (SRT) on cancer-specific outcomes stratified according to the European Association of Urology biochemical recurrence (BCR) risk classification was assessed. While men with high-risk BCR should be offered SRT, surveillance might be a suitable option for those with low-risk BCR.</p

Intermediate term survival following open versus robot-assisted radical cystectomy in the Netherlands:results of the Cystectomie SNAPSHOT study

There is insufficient knowledge on intermediate-term survival of non-metastatic muscle-invasive bladder cancer (MIBC) after open (ORC) versus robot-assisted (RARC) cystectomy, with or without neo-adjuvant chemotherapy (NAC). This retrospective study was performed in 19 Dutch hospitals between 2012 and 2015 to assess the five-year survival after both interventions and the influence of NAC. Out of 1,534 cT1-4N0-1-patients, 1,086 patients were treated with ORC and 389 with RARC. The 5-year survival rate after ORC was 51% (95% CI 47–53) versus 58% after RARC (95% CI 52–63), hazard ratio 1.00 (95% CI 0.84–1.20) after multivariable analysis. 226 of 965 cT2-4aN0 patients were treated with NAC. More patients had ypT0 after NAC than after no NAC (31% vs 15%; p?&lt; 0.01). The best five-year survival was in patients with ypT0 after NAC (89%; 95% CI 81–97). This study shows similar five-year survival of MIBC patients treated with ORC or RARC and shows that the best survival was after NAC